The present invention relates to products used as dietary supplements or nutritional supplements for the supplementation of nutrition and diets by taking substances, mainly of natural origin, which supply elements necessary for nutrition and thus for good maintenance of essential body functions (such as the formation and preservation of the bones, muscles, skin, its related tissues and the like).
More particularly, the present invention relates to a process for obtaining a natural dietary supplement which has proved very effective in the prevention and treatment of osteoporosis and of other diseases mainly due to calcium, magnesium and potassium deficiencies in the body.
At the present state of our technical and scientific knowledge, it is well known that an adequate supply of a number of nutritional substances, commonly called xe2x80x9cnutrientsxe2x80x9d (such as minerals, vitamins, proteins, and others) is of fundamental importance for the proper development of body tissues and for the body""s vital functions and that deficiencies or imbalances of such nutrients are often concomitant with actual pathological conditions (particularly those of a xe2x80x9cdegenerativexe2x80x9d and/or chronic type which may affect various parts of the body, e.g. the skeleton and blood vessels, interalia.
It is also known that the main nutrients are ingested with the diet and, therefore, that, if the latter is sufficiently appropriate and balanced and if the body is in a normally functioning state in terms of the assimilation and conversion of such nutrients, there should be no problems with regard to the maintenance of conditions of good health from this point of view. In actual fact, it often happens that an individual""s diet, even or, indeed, above all in the industrialised countries, presents imbalances due to deficiencies and/or excesses which in the course of time may cause serious damage to health. Many diseases, which are then treated with various drugs, are also often due to an unbalanced nutritional intake and it is well known that these could be prevented or even cured by restoring the lost equilibrium.
It is also known, moreover, that numerous products commonly coming under the definition of dietary supplements have been produced and used to solve the above-mentioned problems and are, therefore, a familiar aspect of the present state of the art. These supplements consist of combinations of various substances (nutrients) obtained by processes of chemical synthesis or extraction of various materials (vitamins, minerals of plant or animal origin) compounded in a particular formula and presented in the form of tablets or capsules or other types of preparations which can be orally taken. The administration of these preparations presents a whole series of drawbacks, the most important of which are: 1) the origin of the nutrients used (obtained by synthesis or extraction), which is often unsuitable for the human body; 2) difficulties of assimilation due to the source and type of the materials used, which substantially limit the bioavailability of the substances administered; 3) the respective proportions of the various nutrients present in the product administered, often predetermined independently of one another, without due regard for the equilibria actually to be found in nature and in metabolic processes and which constitute one of the key factors for the above-mentioned balanced diet required for effective conditions of health and well-being of the body.
As a consequence of the considerations outlined here, the inventor of the present invention concluded that solutions to the aforesaid problems effectively useful for the health and equilibrium of the body should be sought in completely natural preparation processes, by xe2x80x9cpilotingxe2x80x9d exclusively the chemical transformations brought about biologically by micro-organisms such as, for instance, lactobacteria and yeasts so as to influence them in the manner required.
The condition of good development and maintenance of the health of the musculo-skeletal system and in particular of the bones is acknowledged to be a fundamental, widespread health problem.
It is related both to problems of diet and to the use of certain drugs, as well as to the manifestation of degenerative processes as a result of ageing which may lead to the onset of osteoporosis (which consists in a reduced density and resilience of the bones with a consequent increase in their fragility) and of collateral conditions of an inflammatory and painful type leading even to the ultimate risk of sudden fractures (in this case not due to any obvious serious trauma). The subjects most xe2x80x9cat riskxe2x80x9d are women, particularly during or after the period of the menopause, and those individuals with a particular xe2x80x9cgenetic riskxe2x80x9d who specific analyses have identified as being present in 15% or more of the overall population.
A number of drugs effective against this disease are currently available, but it has now been established that the best approach to both the prevention and therapy of osteoporosis must necessarily entail adequate dietary supplementation on the basis of minerals such as calcium and magnesium with the possible addition of vitamin D3. Such xe2x80x9csupplementationxe2x80x9d, however, is mostly implemented by administering poorly assimilated products of unsatisfactory biological quality containing inorganic calcium or calcium which, in any event, is not absorbed in the bowel owing to a series of factors which block its absorption to a substantial extent. As an alternative to such supplementation, diets rich in milk and cheese products are often recommended; these provide a good supply of calcium (and also magnesium), but unfortunately present many problems which are often underestimated, such as: a) problems of poor digestibility or even of lactose intolerance; b) excessively high cholesterol levels; c) unwanted intake of calories and fats.
The inventor of the present invention therefore sought a solution which would yield a product better able to overcome the above-mentioned problems, in the form of a supplement which was demonstrably efficacious, reliable and inexpensive, that is to say by developing a product which: 1) guarantees the supply of adequate amounts of calcium, magnesium and other nutrients which are useful for the bones and metabolism for the purposes of the musculoskeletal functions; 2) ensures assimilation of the various nutrients; 3) assures digestibility and avoids intolerance; and 4) possesses the characteristics of a wholly biocompatible biological substance.
For this purpose, the inventor has found a process which is the subject matter of the present invention, which is delineated in the preamble of claim 1 and whose inventive features are disclosed in the characterizing part of said claim.
The present invention also relates to the dietary supplements obtainable with said process and their use for the prevention and therapy of osteoporosis and of other diseases due substantially to calcium, magnesium and potassium deficiencies.
The process according to the invention makes it possible to obtain a xe2x80x9cnutrient complexxe2x80x9d, by which definition is meant a nutritional substance of natural origin, which is the result of biological processing by micro-organisms (the so-called xe2x80x9cbeneficial micro-organismsxe2x80x9d, such as lactobacilli, etc.), containing all the nutrients desired, and particularly calcium, magnesium and potassium, with the desired characteristics of good assimilation, tolerability and efficacy. The inventor started out by selecting the products obtainable from various types of fermented milk, products which differ both in the type of milk (cow, sheep, goat, mare) and the type of micro-organisms used, as well as in the modalities whereby the fermentation process itself is conducted. A particular type of fermentation product was thus identified, which is akin to a substance traditionally known in countries of the Middle East and Eastern Europe under the name Kefir, endowed with optimal characteristics as a xe2x80x9cnutrient complexxe2x80x9d.
Kefir is a kind of yoghurt, obtainable by fermentation of milk through the dual action of a number of lactobacilli and yeasts, the appropriate combination of which makes it possible to obtain a biologically processed product with the required characteristics. The addition, during the fermentation process, of desired substances (for example, though not exclusively, calcium) allows xe2x80x9cenrichmentxe2x80x9d of the nutrient complex so that it can be used specifically for a certain type of application (for example, for the treatment of osteoporosis). It is the micro-organisms that process one or more minerals, fixing them in their cells and ensuring their bioavailability.
To achieve the desired objectives, the inventor, after meticulously studying the traditional natural processes implemented in the areas mentioned above, concluded that natural food supplements with a highly effective action could be obtained through the processing work of a suitable mixture of micro-organisms in a predetermined sequence, by modifying said processes with targeted additions of useful substances and by appropriately modifying the times and temperatures of the various steps of said processes.
Operating in this way, a process was found which is suitable for producing dietary supplements presenting a high degree of efficacy which reaches an adequate level for the supplements to be used for actual therapeutic purposes.
As is pointed out in the following part of this description, a dietary supplement obtained by means of the process according to the present invention, as a result of the broad spectrum and high concentrations of organic substances with beneficial effects that it contains, not only proves useful as a primary measure, as indicated earlier, for the prevention and therapy of conditions due to calcium, magnesium and potassium deficiencies, but also exerts a secondary beneficial action on various other disorders generated by genetic factors in conjunction with functional imbalances of a chemical nature.